Fresenius Medical Care Holdings, Inc.: FDA recalls

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Share of the events of the firm in Class I

8%

Share of all events on the register in Class I

18%

Events with the status Ongoing

35

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

• FDA enforcement reportsThe FDA search of the weekly enforcement reports.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA: report a problemThe FDA page that shows where a report about a product goes.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Which classes do the FDA recalls of Fresenius Medical Care Holdings, Inc. have?

Class II: 58 events. Class I: 5 events. Class III: 3 events. The class is for the product of a recall. It is not a class of the firm.

Which product types do the FDA recalls of Fresenius Medical Care Holdings, Inc. have?

Device: 56 events. Drug: 10 events.

What is the newest FDA recall of Fresenius Medical Care Holdings, Inc.?

FDA event 98877, which the firm started on 12 May 2026. The first product in the record is: Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

How many FDA recalls of Fresenius Medical Care Holdings, Inc. have the status Ongoing?

35 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.